Unveiling the Microbial Impact on Intestinal Fibrosis
Observational · No treatment assigned · 1 site · IRCCS San Raffaele
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- Adult patients ≥18 and <70 years
- All patients will sign the informed consent
- Given that it is an observational study, also pregnant and breastfeed patients could be included
Plus 4 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2023-11-01 (planned).
- Main results expected around 2024-10-01 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- To perform flow cytometry, RNAseq, metatranscriptomics, transcriptomics and lipidomics on CD and non-IBD cells (1-36 months)
In the researchers’ words
Crohn's disease (CD), belonging to the class of Inflammatory Bowel Diseases, is a chronic inflammatory disorder that may affect any location of the gastrointestinal tract. It is characterized by transmural inflammation and an overwhelming immune response of the gut mucosa, which leads to severe clinical symptoms.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | IRCCS San Raffaele |
| Enrollment | 20 (estimated) |
| Start date | 2023-11-01 |
| Primary completion (est.) | 2024-10-01 |
| First posted | 2023-10-10 |
| Last updated | 2023-10-10 |
| Official title | Unveiling the Microbial Impact on Intestinal Fibrosis: New Insights for the Pathogenesis and Treatment of Crohn's Disease-associated Complications |
| ClinicalTrials.gov ID | NCT06073288 |
Interventions
- Surgical specimens of CD and no-IBD patients (Other)
Specimens of CD patients and patients without IBD-related disease (ex. diverticulitis) will be collected during the surgery, without other risks for the patients, since we will use only material left after pathologist analysis
Full eligibility criteria (from the record)
Inclusion Criteria: * Adult patients ≥18 and <70 years * All patients will sign the informed consent * Given that it is an observational study, also pregnant and breastfeed patients could be included Additionally, for CD patients: \- classification on different stages: (B1 (more inflammatory, non-structuring), B2 (structuring, non-penetrating) and B3 (structuring and penetrating). Patient stratification is based on previous classifications done in accordance with the standard of care through TC, RMI or Ecography. Additionally, for non-IBD patients: \- subjects undergoing surgery for non-IBD diseases (ex. diverticulitis) in accordance with the standard of care Exclusion Criteria: For CD patients: * CD subjects without previously classification in B1, B2, B3 * Patients <18 years or > 70 years * Patients without the signed informed consent For non-IBD patients: * Patients <18 years or > 70 years * Patients without the signed informed consent
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.